- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07690709
Eye-tracking Training for Older Adults
Eye Tracking as an Early Cognitive Intervention for Older Adults With Subjective Memory Complaints
The goal of this clinical trial is to learn if a computerized eye-tracking training program can improve mental health and thinking skills in older adults. The main questions it aims to answer are whether eye-tracking training can lower depressive and anxiety symptoms in older adults, and whether it can improve their ability to control impulses and pay attention.
Researchers will compare older adults who receive eye-tracking training to older adults on a waitlist to see if eye-tracking training leads to greater improvements in mood and thinking skills.
Researchers will randomly assign participants into the experimental group or the waitlist control group. Participants in the experimental group will take part in eye-tracking training three times a week for 18 sessions, over about 1.5 months. Before and after training, participants will answer questions about their mood and take tests of memory, attention, and impulse control. Older adults on the waitlist will complete the same tests but will not receive training until after the study period; they will be offered the same training once their waiting period ends.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hong Kong, Hong Kong, 0000
- Research Center for Neuropsychological Well-being
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Hong Kong, Hong Kong
- International Women's League Neighbourhood Elderly Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Community-dwelling Chinese older adults aged 60 to 80 years
- Able to understand Cantonese/Chinese
- Normal or corrected-to-normal vision
- Willing and able to commit to attending 18 training sessions over the course of the intervention
Exclusion Criteria:
- A history of learning disability, psychiatric disorders, neurological disorders (e.g., head injury or Parkinson's disease), visual and/or hearing impairments, or any other physical disabilities that would affect their performance on neuropsychological assessment or adherence to the intervention
- Prior or concurrent participation in other interventions involving eye-tracking techniques
- Signs of dementia, as indicated by a total score of 18 or below on the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
- Inability to commit to the full course of 18 training sessions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Eye-Tracking Training
Participants receive computerized eye-tracking training for 18 one-hour sessions, three times weekly, over approximately 6 weeks.
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The intervention is a copyrighted computerized training program using a non-contact eye tracker.
Participants are required to fixate on or trace visual targets across six modules of increasing difficulty to improve attention and inhibitory control.
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Sin intervención: Waitlist control
Participants in this group do not receive eye-tracking training during the study period and complete the same baseline and post-assessment schedule as the experimental group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Inhibitory control
Periodo de tiempo: Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Inhibitory Control Index (ICI) in the Eriksen Flanker Test
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Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Sustained attention
Periodo de tiempo: Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Digit Cancellation Index (DCI) in the Digit Cancellation Test
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Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Depressive symptoms
Periodo de tiempo: Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Depressive symptoms are assessed using the 15-item Chinese version of Geriatric Depressive Scale (CGDS-15).
It is a 15-item self-report scale in which participants answer "Yes" or "No" to whether they experienced each of 15 common depressive symptoms in the past week.
Scores range from 0 to 15, with higher scores indicating more depressive symptoms.
A score of 8 or higher indicates clinically significant depressive symptoms.
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Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Anxiety symptoms
Periodo de tiempo: Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Anxiety symptoms are assessed using the 10-item Chinese version of Geriatric Anxiety Scale (CGAS-10).
It is a 10-item self-report measure of anxiety symptoms in older adults.
Higher scores indicate greater severity of anxiety symptoms.
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Baseline and after completion of 18 training sessions (approximately 9 weeks)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2022.625
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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